Catalog Number

803-002

Brand Name

TruTorq Adaptor Sterile, Single Use

Version/Model Number

12 Nm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2022

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

46b30e8d-f4d9-4dca-97e3-27b8cb7992b3

Public Version Date

March 31, 2022

Public Version Number

2

DI Record Publish Date

March 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-